Global Monoclonal Antibodies Market By Source Type (Murine, Humanized, Chimeric, Human), By Disease Indication (Cancer, Infectious Disease, Inflammatory Disease, and Others), By Distribution Channel (Hospital Pharmacy, Retail Pharmacy, and Online Pharmacy), By Region and Companies - Industry Segment Outlook, Market Assessment, Competition Scenario, Trends, and Forecast 2023-2032

Report Overview

The Global Monoclonal Antibodies Market size is expected to be worth around USD 588.0 Billion by 2032 from USD 198.2 Billion in 2022, growing at a CAGR of 11.80% during the forecast period from 2023 to 2032.

Monoclonal antibodies are antibodies made in a laboratory that are made to recognize and bind to particular receptors on the surface of cells. Natural antibodies are complex proteins made by the immune system of the body from a single B cell to recognize and combat foreign invaders like viruses and bacteria. A type of immunotherapy called monoclonal antibody (mAb) therapy makes use of monoclonal antibodies to attach to specific proteins or cells. Replicas of distinct parental cells that are derived from identical immune cells are known as monoclonal antibodies. Owing to their monovalent affinity, these antibodies can bind to a particular antigen when administered. Owing to their site-specificity; these antibodies are an important tool for detecting or purifying substances; As a result, biochemistry, molecular biology, and medicine all rely heavily on them.

Driving Factors

Increasing the Prevalence of Cancer

The monoclonal antibodies market is expected to grow at a rapid rate because of the rising incidence of cancer. Due to the rapid expansion of the global monoclonal antibodies market, many cancers are now being treated with monoclonal antibodies in industrialized nations. According to the GOLOBOCAN study, approximately a million people worldwide died as a result of cancer, as well as new cancer diagnoses. However, the increasing prevalence of the geriatric population will have a positive impact on the sales of mAbs in the upcoming years. The increasing prevalence of chronic diseases such as cardiovascular diseases, cancer, and others is increasing the demand for biologics. Which is anticipated to serve as a key factor propelling the monoclonal antibodies market growth.

Restraining Factors

Strict Regulatory Guidelines for Adoption to Hamper the Market Growth

Even though promising results for these antibodies in the treatment of numerous diseases, the stringent and long regulations for adoption and launch will be a main hindrance to this market. Various clinical studies are withdrawn mostly owing to the failure to meet the strict regulations as well as end results framed by the regulatory authorities. Additionally, potential adverse effects of drugs are the other factors hampering the monoclonal antibodies market growth.

Growth Opportunities

Rise in the Amount of Research & Development Activities       

It is anticipated that the monoclonal antibodies market will expand in the coming years due to the increasing number of R&D activities. The market may expand as a result of novel gene-based therapies, research on how monoclonal antibodies can be used to treat deadly disorders such as diagnosis and treatment of other illnesses like auto-immune, and viral diseases, and government adoption of novel antibodies. For example, Union Chimique Belge (UCB) and Roche, and Genentech signed a license contract to manufacture and market UCB0107, a powerful monoclonal antibody for the treatment of Alzheimer’s disease and advanced supranuclear palsy (PSP). However, research on this drug is still ongoing. Such initiatives are anticipated to open new growth opportunities and positively affect market growth. Moreover, growth opportunities in developing markets are anticipated to offer lucrative opportunities during the forecast period.

Trending Factors

Healthcare Infrastructure Impacts the Current Trends of the Market

The expansion of healthcare infrastructure and an increase in the number of generic manufacturers will further propel the market’s growth rate.

Source Type Analysis

The Human Source Type Held the Largest Revenue Share in The Market

Based on source type, the global monoclonal antibodies market is segmented into murine, humanized chimeric, and human. The human segment accounted for the largest market revenue share of 55.2% during the forecast period; human monoclonal antibodies have effective modulation in effector functions as well as are less immunogenic as related to chimeric and humanized monoclonal antibodies. Such antibodies can be produced by using hybridoma technologies in transgenic mice. Therefore, with recent technological advancements in genetic engineering, the production of fully human mAbs is estimated to gain traction in the near future. Murine antibodies are produced from a murine source, while chimeric antibodies combine murine and human antibodies

 Due to their widespread use against a wide range of target antigens, including cancer cells, immunosuppressive molecules, and immunomodulatory molecules, humanized mAbs are anticipated to exhibit the fastest CAGR during the forecast period. The fact that these antibodies are less immunogenic than chimeric mAbs supports the demand for them as well. However, the fact that these antibodies are more immunogenic than human mAbs may limit market expansion.

By Disease Indication Analysis

The Cancer Segment Accounted for the Highest Revenue Share of the Market

Based on disease indication, the monoclonal antibodies market is divided into cancer, infectious disease, inflammatory disease, and others. The cancer segment dominated the global monoclonal antibody market based on the indication. The simple reason for this growth is that more individuals are getting cancer, and more individuals are looking for monoclonal antibodies to treat different types of cancer, such as lung cancer, breast cancer, colorectal cancer, ovarian cancer, and prostate cancer. One major factor that has contributed to the significant demand for monoclonal antibodies among cancer patients is the increased efficacy of mAbs in the treatment of cancer with minimal or no side effects. The mAbs’ dominance in the global market is due to rising healthcare costs and increased awareness of their effectiveness in treating cancer.

During the forecast period, the autoimmune diseases market is anticipated to be the most opportunistic. The use of mAbs in the treatment of autoimmune diseases has increased as a result of rising technological advancements and increased funding for their research and development. The major factors driving the expansion of the autoimmune diseases segment in the global monoclonal antibody market include the rising prevalence of rheumatoid arthritis, the expanding use of biosimilars, and the most recent product launches by manufacturers.

By Distribution Channel Analysis

Strong Government support to approval the Hospital Pharmacy Segment

Based on distribution channels, the global monoclonal antibodies market is divided into hospital pharmacies, retail pharmacies, and online pharmacies.  The hospital pharmacy segment dominated for the highest market revenue share of 43.0% in 2022. This is because of the rising prevalence of chronic diseases such as cancer, autoimmune conditions, and rheumatoid arthritis among the population, which has led to an increase in the number of hospital admissions. Hospital pharmacies in the market have seen an increase in sales revenue as a result of increased access to cutting-edge healthcare facilities. Hospital pharmacies are a convenient location for purchasing a variety of drugs, including mAbs, due to the extensive product selection and the wider availability of drugs.

During the forecast period, it is anticipated that the fastest-growing segment will be the online pharmacy. The global expansion of this market is significantly aided by the expanding use of the Internet, the availability of a wider variety of medications, the speed of home delivery, the ease with which payment can be processed, and the substantial discounts offered by online pharmacies.

Key Market Segments:

By Source Type

• Murine
• Humanized
• Chimeric
• Human

By Disease Indication

• Cancer
• Infectious Disease
• Inflammatory Disease
• Others

By Distribution Channel

• Hospital Pharmacy
• Retail Pharmacy
• Online Pharmacy

COVID-19 Impact Analysis

COVID-19 Had a Significant Impact on the Financial Situation of All Industries

The outbreak of COVID-19 and subsequent lockdowns in numerous nations had a significant impact on the financial situation of businesses in all industries. One of the areas where the pandemic had a significant impact was the private healthcare industry. The demand for monoclonal antibodies has increased as a result of the COVID-19 outbreak. The development of effective treatments has been sparked by the sudden rise in the number of people who have COVID-19 and the risk of death that comes with it. In addition, a number of industry participants are actively involved in the creation of novel monoclonal antibodies for the treatment and prevention of the COVID-19 virus due to the virus’s potential to reduce the disease burden. A wide range of pharmaceutical approvals for emergency use in COVID-19 patients’ treatment and a high number of active clinical trials to develop novel pharmacological therapies accelerated market growth during the pandemic.

Regional Analysis

North America Region Accounted Significant Revenue Share of the Global Monoclonal Antibodies Market

North America recorded the highest market revenue share of 46.5% during the forecast period. Owing to the existence of an extremely developed healthcare organization, high patient awareness, as well as growth in cancer research prospects, amid other factors. This is because significant key players are present, and increasing healthcare costs will further increase the market’s growth rate in this region. Additionally, the region’s market growth rate will be further accelerated by the high prevalence of chronic diseases and the rising number of R&D activities.

Asia Pacific region is anticipated to show the most rapid growth rate over the forecast period. Owing to the rising disposable income, accessibility of a huge patient pool for mAb cancer therapeutics, as well as rising issues in healthcare.

Key Regions and Countries Covered in this Report:

• North America
  • The US
  • Canada
  • Mexico
• Western Europe
  • Germany
  • France
  • The UK
  • Spain
  • Italy
  • Portugal
  • Ireland
  • Austria
  • Switzerland
  • Benelux
  • Nordic
  • Rest of Western Europe
• Eastern Europe
  • Russia
  • Poland
  • The Czech Republic
  • Greece
  • Rest of Eastern Europe
• APAC
  • China
  • Japan
  • South Korea
  • India
  • Australia & New Zealand
  • Indonesia
  • Malaysia
  • Philippines
  • Singapore
  • Thailand
  • Vietnam
  • Rest of APAC
• Latin America
  • Brazil
  • Colombia
  • Chile
  • Argentina
  • Costa Rica
  • Rest of Latin America

• Middle East & Africa
  • Algeria
  • Egypt
  • Israel
  • Kuwait
  • Nigeria
  • Saudi Arabia
  • South Africa
  • Turkey
  • United Arab Emirates
  • Rest of MEA

Market Share & Key Players Analysis:

By taking considered advantages that can help them expand and improve their product line, major market players are driving market expansion. For example, Sanofi S.A. and Blackstone Life Sciences signed an association agreement in March to accelerate the growth of a hypodermal formulation of Sarclisa mAb for the treatment of multiple myeloma patients. In the global market for monoclonal antibodies, some of the major players include Novartis AG, Pfizer Inc., Sanofi, Mylan N. V, Lupin, Biogen Inc. F Hoffmann-La Roche Ltd. Eli Lilly and Company, and other prominent players.

Key Market Players

The following are some of the major players in the global monoclonal antibodies market

• Novartis AG
• Pfizer Inc.
• GlaxoSmithKline plc
• Sanofi S.A.
• Mylan N.V
• Zydus Cadila
• Lupin
• Biogen Inc.
• Hoffman-La Roche Ltd.
• Bristol Myers Squibb
• Merck KAGA
• Viatris Inc.
• Eli Lilly and Company
• Amgen Inc.
• Johnson & Johnson
• Merck & Co, Inc.
• AbbVie Inc.
• Regeneron Pharmaceuticals Inc.
• Other Key Players

Recent Developments:

• November 2021- Opdivo (nivolumab) and Yervoy (ipilimumab) were approved by Bristol-Myers Squibb Company as first-line treatments for metastatic or recurrent non-small cell lung cancer in combination with limited chemotherapy. The treatment is available to those with any illness, squamous or non-squamous, regardless of whether PD-L1 expression is present. This application was evaluated using the FDA’s Real-Time Oncology Examine (RTOR) pilot program, which targets to ensure that patients receive safe and effective medicines as soon as possible.
• March 2022- Sanofi, S.A. and Blackstone Life Sciences enter a partnership to accelerate the expansion of subcutaneous formulation of Sacclisa monoclonal antibodies for the treatment of patients with multiple myeloma.

Report Scope: